Regulatory Professional

2 months ago

Bengaluru Karnataka, India Novo Nordisk Full time

Regulatory Professional

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:RA CMC & Device**About the Department**
- RA CMC & Device Bangalore in Global Business Services (GBS) Bangalore is a part of Bangalore Global Development hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product and device approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise in terms of CMC & Medical Devices, Combination Products and work very closely with our colleagues in Denmark (DK) as well as colleagues in our affiliates all over the world. That makes Regulatory Affairs truly interesting and challenging to work.**The Position**- Compile, review and submit Technical Documentation and submission packages, participate in meetings as appropriate.
- Handle Change Requests (CR), CAPA cases within area of responsibility.
- Review of Device documentation, protocols and reports within area of responsibility. Assess the appropriateness of scientific/technical documentation for specific regulatory purposes.
- Responsible for archiving and retrieving documentation in current archiving system and will represent RA in Notified Body and Health Authority Audits.
- Active participation in Device core groups (development, production and launch coordination, product maintenance) and GRTs (Global Regulatory Team).

**Qualification**
- More than 5 years of experience in related field along with Graduate or Post Graduate Degree Pharma, Biomedical and Engineering graduates preferred.
- Experience in handling regulatory submissions of medical devices or drug device combination products across the globe.
- Experience in handling post market changes.
- Knowledge on MDR and Current Standards is mandatory.
- Knowledge on Software as Medical Device and exposure to Notified Body audits and interactions is added advantage.
- Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.

**Working At Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales
- we're all working to move the needle on patient care.**Contact**Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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